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Defining and labeling disease-modifying treatments for Alzheimer's disease
Alzheimer's & Dementia , 09/24/09
Cummings JL – A combination of clinical outcomes and biomarker measures is a more likely pathway to a disease–modifying claim. Labeling of disease–modifying agents might refer to slowing of disease progression, delay in reaching predefined disease milestones, or reduction in progression of a biomarker such as cerebral atrophy or ventricular enlargement on MRI. Prevention claims will depend heavily on biomarker outcomes.
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